A Phase II Study of Pegylated Interferon Alfa-2b for the Adjuvant Treatment of Melanoma Subjects in Russia (MK-4031-400)

Phase 2

Completed

Brief Summary: This study will assess the safety of Pegylated Interferon Alfa-2b (PEG-IFN) as an adjuvant treatment for melanoma.

Recruitment & Eligibility

Inclusion Criteria

Competent to self-administer the subcutaneous injections of PEG-IFN
Histologically documented involved regional lymph nodes of a primary cutaneous melanoma or unknown primary, meeting the study's staging criteria
Had the primary melanoma completely resected with adequate surgical margins and undergone operation for positive regional lymph nodes within 84 days of study start
Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1
Adequate hepatic, renal and bone marrow function as defined by study parameters obtained within 4 weeks prior to study start
For a female subject who is of childbearing potential or male participant with female sexual partner who is of childbearing potential, agree to use acceptable methods of contraception for at least 2 weeks prior to study start and continue until at least 6 months after last dose of study medication, or longer if dictated by local regulations

Exclusion Criteria

Mucous membrane melanoma or ocular melanoma
Known hypersensitivity to the components of study drug (including acetaminophen), or its analogs
Evidence of distant or non-regional lymph node metastases or in-transit metastases
Disease that cannot be completely surgically resected
Prior malignancy within the past 5 years other than surgically cured non-melanoma skin cancer or cervical carcinoma in situ
Severe cardiovascular disease, i.e. arrhythmias, requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease
Hepatic decompensation
Thyroid dysfunction not responsive to therapy
Uncontrolled diabetes mellitus
Clinically active autoimmune disease
Clinically active and/or uncontrolled infection, including active hepatitis
Human immunodeficiency virus (HIV)
History of neuropsychiatric disorder requiring hospitalization
Actively abusing alcohol or drugs
Pregnant, lactating, or of reproductive potential and not using an effective means of contraception
Medical condition requiring chronic systemic corticosteroids
Received any experimental therapy within 30 days prior to enrolling in this study
Received any prior chemotherapy, immunotherapy, hormonal or radiation therapy for melanoma
Previously received interferon-α for any reason
Known serious hypersensitivity reaction to PEG-IFN or interferon alfa-2b

Arm && Interventions

Group	Intervention	Description
PEG-IFN	Pegylated Interferon Alfa-2b	6.0 μg/kg/week subcutaneous administration during the Induction Phase of 8 weeks followed by a dose of 3.0 μg/kg/week subcutaneous administration in the Maintenance Period (Week 8 to Month 12)

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Experiencing Adverse Events (AEs)	From first dose through follow-up; up to 13 months	An adverse event was any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.
Percentage of Participants Discontinuing Study Drug Because of AEs	From first dose to last dose of treatment; up to 12 months	An adverse event was any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.

Secondary Outcome Measures